Label: DR.CEURACLE HYDRA BARRIER SUNSCREEN- zinc oxide lotion
- NDC Code(s): 84773-001-01, 84773-001-02, 84773-001-03
- Packager: Leegeehaam Cosmetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 13, 2025
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- Official Label (Printer Friendly)
- Active Ingredient...Purpose
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Uses
Helps prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away. -
Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:- Limit time in the sun, especially from 10 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
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Inactive ingredients
Water, Propylheptyl Caprylate, Butyloctyl Salicylate, Propanediol, Caprylyl Methicone, Isododecane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Magnesium Sulfate, Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, 1,2-Hexanediol, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glyceryl Caprylate, Caprylyl Glycol, Octyldodecanol, Ethylhexylglycerin, Echium Plantagineum Seed Oil, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hyaluronate, Panthenol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid
- Other information
- Dosage and Administration
- Keep out of reach of children
- WARNINGS
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR.CEURACLE HYDRA BARRIER SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84773-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 170 mg in 1 mL Inactive Ingredients Ingredient Name Strength LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: H49Q67JS3B) ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW) CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) HYALURONATE SODIUM (UNII: YSE9PPT4TH) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB) PANTHENOL (UNII: WV9CM0O67Z) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) PROPANEDIOL (UNII: 5965N8W85T) PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ISODODECANE (UNII: A8289P68Y2) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84773-001-03 10 in 1 BOX 02/01/2025 1 NDC:84773-001-02 1 in 1 PACKAGE 1 NDC:84773-001-01 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2025 Labeler - Leegeehaam Cosmetics (689716868) Registrant - KOLMAR KOREA Co., Ltd. (557822156) Establishment Name Address ID/FEI Business Operations KOLMAR KOREA Co., Ltd. 963271745 manufacture(84773-001)
